Naproxen
- Product NDC
- 58118-0199
- 11-digit product format
- 581180199
- Labeler code
- 58118
- Product ID
- 58118-0199_ebc84746-7763-38a8-e053-2995a90ae36a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Clinical Solutions Wholesale, LLC
- Application
- ANDA078250
- Marketing category
- ANDA
- Marketing start
- 2007-07-01
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 58118-0199 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 58118-0199 | 58118-0199-8 | D | Discontinued by firm | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58118-0199-8 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58118-0199-8 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 58118-0199-8 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 58118-0199-8 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 58118-0199-8 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 58118-0199-8 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 58118-0199-8 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 58118-0199-8 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 58118-0199-8 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 58118-0199-8 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 58118-0199-8 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 58118-0199-8 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 58118-0199-8 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 58118-0199-8 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 58118-0199-8 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078250-001 | NAPROXEN | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | |
| A078250-002 | NAPROXEN | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | |
| A078250-003 | NAPROXEN | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078250-001 | AB |
| A078250-002 | AB |
| A078250-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078250-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078250-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078250-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078250-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078250-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078250-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078250-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078250-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078250-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078250-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078250-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078250-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078250-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078250-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078250-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078250-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078250-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078250-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078250-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078250-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078250-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078250-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078250-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078250-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078250-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078250-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078250-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078250-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078250-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078250-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078250-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078250-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078250-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078250-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078250-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078250-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078250-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078250-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078250-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078250-001 | AB | 1 | 1e350fbaab3a… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58118-0199-8 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1e50-111a-e063-dadaa90a10e2 | NAPROXEN Tablets, USP NAPROXEN SODIUM Tablets, USP |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58118-0199 | NAPROXEN TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC] | 7 | Legacy NDC | 20221027_afe05212-343e-43b7-bb47-232a800ff060.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Naproxen | NAPROXEN | REMEDYREPACK INC. | 88a548d1-97c0-46d0-825a-75ef689d6470 | 2026-08-10 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | Coupler LLC | 545fe39a-4777-b149-e063-6394a90a53cf | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | Coupler LLC | 53e6519a-cb52-85e2-e063-6394a90abdcf | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | Coupler LLC | 52b8e52e-73be-3423-e063-6294a90af6e0 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | 0041b483-34db-49a6-8665-f87e286cd0b8 | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | A-S Medication Solutions | 4e97e645-552d-424b-990a-f94349a86f17 | 2026-01-30 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | A-S Medication Solutions | 000155a8-709c-44e5-a75f-cd890f3a7caf | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | A-S Medication Solutions | d06db628-f6f0-48e2-b538-69c0837c49e3 | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | A-S Medication Solutions | 9d28422f-6f25-4f14-9272-e0907c971f33 | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | Preferred Pharmaceuticals Inc. | 87acd650-ea8a-4396-be72-5568c4b1755c | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen Sodium | NAPROXEN SODIUM | Glenmark Pharmaceuticals Inc., USA | 6c5bb008-e66f-4ef0-bf84-aca7eb5983e9 | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | American Health Packaging | 86a3e612-3bfe-432f-9afd-972bb8a6644e | 2025-09-25 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | A-S Medication Solutions | e63a034d-23ef-458f-88ed-8b6d73699621 | 2025-04-17 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | Preferred Pharmaceuticals Inc. | 727913f6-9542-4a2d-9318-4b7ff521bffd | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | Advanced Rx of Tennessee, LLC | af9aa7a0-e287-5935-e053-2995a90a1d11 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | A-S Medication Solutions | bce23087-f055-4234-b75d-69dd43233190 | 2024-10-16 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | da61463f-f87b-4aba-b538-7264252cadb8 | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | 1fe9a6fc-940e-4a18-b3e9-b204fd67f263 | 2024-09-03 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 205b1159-06e5-0d48-e063-6294a90acbd8 | 2024-08-23 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | NuCare Pharmaceuticals, Inc. | 46dd3908-6feb-4f50-e054-00144ff88e88 | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58118-0199-8 | 58118019908 | 30 TABLET in 1 BLISTER PACK (58118-0199-8) | 30 tablet | 2017-03-28 | 0000-00-00 | No | No | Current |